Company ยท US
Hybritech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 14 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 5 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 4 |
| DGC | Ige, Antigen, Antiserum, Control | 4 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 3 |
| DBF | Ferritin, Antigen, Antiserum, Control | 3 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JMB | Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 1 |
| JZT | Fluorometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 1997 | K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | CIN |
| Aug 19, 1996 | K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY Hybritech, Inc. | CIN |
| Jan 11, 1994 | K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY Hybritech, Inc. | CIN |
| Feb 17, 1993 | K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET Hybritech, Inc. | JJX |
| Jul 30, 1992 | K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO Hybritech, Inc. | JFH |
| Jul 17, 1992 | K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL Hybritech, Inc. | JJX |
| Jul 17, 1992 | K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET Hybritech, Inc. | JJX |
| Jun 9, 1992 | K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHY |
| Aug 28, 1991 | K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET Hybritech, Inc. | JJX |
| Jul 24, 1991 | K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | GTZ |
| Oct 3, 1990 | K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | GTY |
| Oct 31, 1989 | K895094 | TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | CEP |
| Sep 13, 1989 | K894761 | TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | CGJ |
| Dec 2, 1988 | K884085 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHY |
| Aug 25, 1987 | K872131 | TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | CEP |
| Jun 19, 1987 | K872063 | TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II Hybritech, Inc. | JHY |
| Jun 3, 1987 | K871235 | TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT Hybritech, Inc. | JHI |
| Apr 8, 1987 | K870521 | TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY Hybritech, Inc. | JHI |
| Mar 10, 1987 | K870520 | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | CGJ |
| Mar 10, 1987 | K865057 | TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JHI |
| Jan 5, 1987 | K864945 | TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | JFH |
| Dec 22, 1986 | K863841 | TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE Hybritech, Inc. | LCX |
| Nov 21, 1986 | K863861 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA Hybritech, Inc. | JHI |
| Nov 21, 1986 | K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN Hybritech, Inc. | CFT |
| Nov 21, 1986 | K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM Hybritech, Inc. | JLW |
| Nov 3, 1986 | K863858 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- Hybritech, Inc. | DGC |
| Oct 8, 1986 | K863345 | TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | DBF |
| Aug 19, 1986 | K862956 | ICON READER Hybritech, Inc. | JQT |
| Aug 15, 1986 | K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM Hybritech, Inc. | JZT |
| Apr 29, 1986 | K860984 | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT Hybritech, Inc. | CEP |
| Apr 4, 1986 | K860778 | TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | GTZ |
| Mar 5, 1986 | K860542 | TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | JHI |
| Mar 5, 1986 | K860221 | ENCORE PROLACTIN REAGENT Hybritech, Inc. | CFT |
| Jan 1, 1986 | K853069 | TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | LFX |
| Jul 12, 1985 | K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER Hybritech, Inc. | JJF |
| Jun 25, 1985 | K851950 | TANDEM E PAP Hybritech, Inc. | JFH |
| Mar 21, 1985 | K850680 | ENCORE FERRITIN REAGENT Hybritech, Inc. | JMB |
| Mar 4, 1985 | K850159 | TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | JHI |
| Jan 18, 1985 | K845024 | BAKER CKMB REAGENT SET Hybritech, Inc. | JHY |
| Nov 13, 1984 | K843804 | TANDEM - EPRL Hybritech, Inc. | CFT |
| Oct 11, 1984 | K843395 | ENCORE TSH REAGENT Hybritech, Inc. | JLW |
| Oct 4, 1984 | K843407 | ENCORE HCG REAGENT Hybritech, Inc. | JHI |
| Oct 1, 1984 | K843408 | ENCORE IGE REAGENT Hybritech, Inc. | DGC |
| Aug 23, 1984 | K842633 | TANDEM FAST VISUAL HCG ASSAY KIT - Hybritech, Inc. | JHI |
| Feb 21, 1984 | K834300 | HYBRITECH DATA STATION Hybritech, Inc. | JQP |
| Feb 3, 1984 | K834000 | TANDEM VISUAL HCG IMMUNOENZYMETRIC Hybritech, Inc. | JHI |
| Jan 18, 1984 | K833194 | TANDEM R-TOTAL B-GCG KIT Hybritech, Inc. | JHI |
| Oct 31, 1983 | K832813 | TANDEM-E THYROID STIMULATING HORMONE KIT Hybritech, Inc. | JLW |
| Aug 31, 1983 | K832397 | HYBRITECH 405-500 NM FILTER MODULE Hybritech, Inc. | JJQ |
| Aug 26, 1983 | K832364 | PHOTON IMMUNOASSAY ANALYZER Hybritech, Inc. | JJQ |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||